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Recall Observatory FDA recall evidence

Device product

Reliance 1227 Cart and Utensil Washer/Disinfector Product Usage: Usage: The Reliance 1227 Cart and Utensil Washer/Disinfector is intended for use in the cleaning and low-level disinfection of bedpans and urinals, basins, carts, beds, theater shoes and other miscellaneous reusable items used in the care of patients.

Z-2036-2014

June 30, 2014

Class III

Product summary

Firm
Steris Corporation
Event
Event 68696
Status
Terminated
Classification
Class III
Quantity
37
Official record key
device-enforcement:Z-2036-2014

Official wording

Reason: STERIS has identified that deformation of the washers door handle pin may occur when the door handle is rotated with sufficient force. Should deformation and/or breakage of the door handle pin occur there is a potential for the washer door to become inoperable.

Code information: Serial Number Range: 3632511020 - 3613214010

Distribution pattern: US Nationwide Distribution - in the states of AL, AR, CA, DE, FL, GA, IL, IA, LA, MA, MI, NJ, NY, OH, OK, OR, SC, TX, VA. and in the country of Canada.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    STERIS has identified that deformation of the washers door handle pin may occur when the door handle is rotated with sufficient force. Should deformation and/or breakage of the door handle pin occur there is a potential for the washer door to become inoperable.